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Recruiting NCT05153694

Infectious Complications After Cystectomy: A Prospective Observational Study

— Observational Bladder Cancer Infections Infection, Bacterial Infection, Hospital

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cystectomy.
Who it may be relevant to
Registry conditions: Bladder Cancer, Infections, Infection, Bacterial, Infection, Hospital. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

Patients undergoing cystectomy for either oncological or non-oncological indications are prospectively enrolled following informed consent. This study design incorporates a comprehensive medical history, detailed prospective documentation of clinicopathological parameters, and serial measurements of infectious markers pre- and post-operatively. In-hospital complications are meticulously recorded, and long-term outcomes assessed through structured follow-up interviews at 3, 6, and 12 months. These follow-ups utilize standardized questionnaires to evaluate post-discharge infectious complications and gather patients' perspectives on their in-hospital experiences, providing a robust understanding of both clinical outcomes and patient-reported experiences.

Detailed description

Aims of the study:

1. Prospective evaluation of the association between preoperative interleukin-6 levels and local tumor stage in patients undergoing radical cystectomy 2. Prospective assessment of interleukin-6, procalcitonin and wound drainage culture as early indicators for perioperative infectious complications after cystectomy 3. Prospective evaluation of physician-assessed vs. patient-reported grading of complications after cystectomy 4. Prospective comparison of infectious complications within the first 12 months after cystectomy: ileal neobladder vs. ileal conduit 5. Prospective evaluation of the association between in-hospital complications after cystectomy and quality of life after three months

Interventions

  • Procedure Cystectomy
    Removal of the urinary bladder

Primary outcome measures

  • Infectious parameters on the first postoperative day after cystectomy [Time frame: First postoperative day]
  • Postoperative fever [Time frame: Surgery - discharge]
  • Antibiotic use [Time frame: Surgery - discharge]
  • In-hospital complications [Time frame: Surgery - discharge]
  • Antibiotic therapy within the first year after discharge [Time frame: 0-12 months after discharge]
  • Fever within the first year after discharge [Time frame: 0-12 months after discharge]
  • Emergency consultation [Time frame: 0-12 months after discharge]
  • Inpatient admission [Time frame: 0-12 months after discharge]
  • Preoperative interleukin-6 level [Time frame: 1 day before surgery]
Secondary outcome measures (5)
  • IMCU/ICU nights [Time frame: Surgery - discharge]
  • Duration of hospital stay [Time frame: Surgery - discharge]
  • Subjective grading of in-hospital complications [Time frame: Assessed time: Surgery - discharge. Assessed 3 months after discharge]
  • Rating of the pre-operatively provided medical information [Time frame: Assessed 3 months after discharge]
  • Health related quality of life [Time frame: Assessed 3 months after discharge]

Eligibility criteria

Inclusion criteria

  • Disease which requires removal of the urinary bladder

Exclusion criteria

  • Patient does not want to participate

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • Urology Department - LMU Klinikum — Munich

Publications

  • Ebner B, Hirsch J, Holz A, Eismann L, Hermans J, Pyrgidis N, Kidess M, Semmler M, Brinkmann I, Aydogdu C, Chaloupka M, Apfelbeck M, Lindner AK, Weinhold P, Stief CG, Volz Y, Schulz GB. Prospective Evaluation of Blood-based and Microbiological Early Indicators of In-hospital Infectious Complications After Open Cystectomy. Eur Urol Open Sci. 2025 Nov 18;83:1-8. doi: 10.1016/j.euros.2025.10.019. eCol PMID 41334533
  • Ebner B, Hirsch J, Holz A, Volz Y, Eismann L, Hermans J, Pyrgidis N, Kidess M, Semmler M, Fouladgar ST, Papadopoulos I, Chaloupka M, Apfelbeck M, Marcon J, Weinhold P, Ewert A, Kazmierczak P, Stief CG, Schulz GB. Association of interleukin-6 serum levels with local tumor stage and lymph node metastasis of urothelial carcinoma. Urol Oncol. 2025 Dec;43(12):693.e1-693.e8. doi: 10.1016/j.urolonc.2025. PMID 41006129
  • Ebner B, Hirsch J, Holz A, Volz Y, Eismann L, Hermans J, Pyrgidis N, Kidess M, Semmler M, Brinkmann I, Aydogdu C, Chaloupka M, Lindner AK, Weinhold P, Stief CG, Schulz GB. Discrepancies between physician-assessed and patient-reported complications after cystectomy - a prospective analysis. World J Urol. 2025 Feb 10;43(1):115. doi: 10.1007/s00345-025-05487-7. PMID 39928165

Identifiers

NCT: NCT05153694 · RCXINFLMU

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗